Vacation - Spf 30 Baby Oil

Vacation - Spf 30 Baby Oil
SPL v2
SPL
SPL Set ID f6030311-5287-3aa3-e053-2995a90a1b87
Route
TOPICAL
Published
Effective Date 2023-03-09
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Homosalate (9.8 g) Octisalate (4.9 g) Avobenzone (2.8 g) Octocrylene (9.5 g)
Inactive Ingredients
Levomenol Butyloctyl Salicylate Alkyl (c12-15) Benzoate Calendula Officinalis Flower Trimethylpentanediol/adipic Acid/glycerin Crosspolymer (25000 Mpa.s) Matricaria Recutita Flowering Top Sunflower Oil Jasminum Officinale Flower Medium-chain Triglycerides Methyl Dihydroabietate Polyester-8 (1400 Mw, Cyanodiphenylpropenoyl Capped) Rosa Canina Seed Oil Jojoba Oil Tocopherol Safflower Oil Isopropyl Myristate

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2023-01-01

Description

Avobenzone (2.8%) Homosalate (9.8%) Octisalate (4.9%) Octocrylene (9.5%)


Medication Information

Description

Avobenzone (2.8%) Homosalate (9.8%) Octisalate (4.9%) Octocrylene (9.5%)

Uses

• Helps prevent sunburn

• If used as directed with other sun protection measures (see Directions ), decreases the risk of skin cancer and early skin aging caused by the sun.

Section 50565-1

Keep out of reach of children. In case of ingestion, get medical help or contact a Poison Control Center right away.

Section 51727-6

Bisabolol, Butyloctyl Salicylate, C12-15 Alkyl Benzoate, Calendula Officinalis Flower Extract, Caprylic/Capric Triglyceride, Carthamus Tinctorius (Safflower) Seed Oil, Chamomilla Recutita (Matricaria) Flower Extract, Fragrance, Helianthus Annuus (Sunflower) Seed Oil, Isopropyl Myristate, Jasminum Officinale (Jasmine) Extract, Methyl Dihydroabietate, Polyester-8, Rosa Canina (Rose) Seed Oil, Simmondsia Chinensis (Jojoba) Seed Oil, Tocopherol (Vitamin E), Trimethylpentanediol/ Adipic Acid/Glycerin Crosspolymer

Section 51945-4

Section 55105-1

Sunscreen

Section 55106-9

Avobenzone (2.8%)

Homosalate (9.8%)

Octisalate (4.9%)

Octocrylene (9.5%)

Warnings

For external use only

Do not use on damaged or broken skin

When using this product, keep out of eyes. Rinse with water to remove.

Stop use and ask a doctor if rash occurs

Directions

• Apply liberally 15 minutes before sun exposure.

• Reapply at least every 2 hours

• Use a water-resistant sunscreen if swimming or sweating.

Sun Protection Measures. Spending time in the sun increases your risk of skin cancer and early skin aging. To decrease the risk, regularly use a sunscreen with a broad spectrum SPF of 15 or higher and other sun protection measures including: limit time in the sun, especially from 10 a.m. - 2 p.m. wear long-sleeve shirts, pants, hats, and sunglasses • Children under 6 months of age: ask a physician.

Other Information

• Protect this product from excessive heat and direct sun.


Structured Label Content

Uses

• Helps prevent sunburn

• If used as directed with other sun protection measures (see Directions ), decreases the risk of skin cancer and early skin aging caused by the sun.

Section 50565-1 (50565-1)

Keep out of reach of children. In case of ingestion, get medical help or contact a Poison Control Center right away.

Section 51727-6 (51727-6)

Bisabolol, Butyloctyl Salicylate, C12-15 Alkyl Benzoate, Calendula Officinalis Flower Extract, Caprylic/Capric Triglyceride, Carthamus Tinctorius (Safflower) Seed Oil, Chamomilla Recutita (Matricaria) Flower Extract, Fragrance, Helianthus Annuus (Sunflower) Seed Oil, Isopropyl Myristate, Jasminum Officinale (Jasmine) Extract, Methyl Dihydroabietate, Polyester-8, Rosa Canina (Rose) Seed Oil, Simmondsia Chinensis (Jojoba) Seed Oil, Tocopherol (Vitamin E), Trimethylpentanediol/ Adipic Acid/Glycerin Crosspolymer

Section 51945-4 (51945-4)

Section 55105-1 (55105-1)

Sunscreen

Section 55106-9 (55106-9)

Avobenzone (2.8%)

Homosalate (9.8%)

Octisalate (4.9%)

Octocrylene (9.5%)

Warnings

For external use only

Do not use on damaged or broken skin

When using this product, keep out of eyes. Rinse with water to remove.

Stop use and ask a doctor if rash occurs

Directions

• Apply liberally 15 minutes before sun exposure.

• Reapply at least every 2 hours

• Use a water-resistant sunscreen if swimming or sweating.

Sun Protection Measures. Spending time in the sun increases your risk of skin cancer and early skin aging. To decrease the risk, regularly use a sunscreen with a broad spectrum SPF of 15 or higher and other sun protection measures including: limit time in the sun, especially from 10 a.m. - 2 p.m. wear long-sleeve shirts, pants, hats, and sunglasses • Children under 6 months of age: ask a physician.

Other Information

• Protect this product from excessive heat and direct sun.


Advanced Ingredient Data


Raw Label Data

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